Person:

Fitzpatrick, Caitlin Noelle

The history of research on prisoners in the United States is marred with a shameful past of abuse and coercion. With the development of research ethics arising from the Nuremberg Code and the Belmont Report, a critical light was shone on these oppressive practices. In 1974, the Department of Health and Human Services commissioned a group to investigate the conditions under which prisoners were used a research subjects and to formulate recommendations to guide clinicians in the future. The results of this Commission Report paved the way for Subpart C of the HHS regulations, which classifies prisoners as a vulnerable population and created a de facto ban on the use of inmates in any research study that received federal funding. What made this situation particularly noteworthy was the position of the FDA following this eventful change in regulation. Initially, the FDA proposed a rule similar to that of HHS which would have effectively barred the use of prisoners in all clinical research on FDAregulated products, even that which was privately funded. This proposal was met with staunch resistance, and a lawsuit filed by prisoners and a pharmaceutical company claimed that their constitutional rights would be violated by this de facto ban. The FDA eventually settled the case, and never again revisited the issue. But recently, the question of the propriety of using prisoners in clinical trials has once again entered the public consciousness. The vast discrepancy in approaches to this sensitive issue by the two major bodies tasked with its regulation yields fruitful insight into the moral and ethical implications of research on prisoners. Strong advocates on both sides of the issue insist that respect for persons, beneficence, and justice all weigh heavily in their favor. These issues come most starkly into relief when viewed through an Eighth Amendment paradigm of “cruel and unusual punishment,” as well as a Fourteenth Amendment analysis under a “due process” and “equal protection” framework. The timeliness of this issue is apparent given the recent developments in this area of bioethics which has been relatively dormant for decades. A report by the Institute of Medicine in 2006, followed by an Advance Notice of Proposed Rulemaking from the HHS in 2011, indicates that change is afoot. Now is the critical moment to appraise the situation and strike the appropriate balance between protecting prisoners from abuse, universalizing the regulatory landscape to promote medical progress, and ensuring that the constitutional rights of prisoners as a class are defended.